Firmonertinib Versus Platinum Based Chemotherapy as First-line Treatment for NSCLC With EGFR PACC or EGFR l861q Mutation
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorAllist Pharmaceuticals, Inc.
About this trial
This study is a randomized, open, multicenter phase III clinical study, which aims to evaluate the efficacy and safety of firmonertinib mesylate compared with platinum based chemotherapy for patients with locally advanced or metastatic NSCLC who have not been treated with systemic antitumor therapy and carry EGFR PaCC mutation or EGFR l861q mutation.
Eligible patients were stratified by EGFR mutation type and CNS metastasis at the time of enrollment. Approximately 300 patients would be randomly assigned 1:1 to receive either firmonertinib mesylate (240mg, orally on an empty stomach daily) or platinum containing dual agent chemotherapy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Voluntarily sign the informed consent form (ICF).
Age ≥18 years at the time of ICF signing.
No prior local therapy (e.g., radiotherapy)
Not used for biopsy during screening
Disqualifiers
Histologically/cytologically confirmed tumor with >10% neuroendocrine carcinoma, sarcomatoid carcinoma, or squamous cell components.
Known ALK-positive, ROS1-positive, RET fusion-positive, NTRK fusion-positive, BRAF V600E mutation, MET exon 14 skipping mutation, or other targetable alterations with approved therapies.
Systemic anti-tumor therapy for advanced/metastatic NSCLC (e.g., chemotherapy/targeted/immunotherapy). Neoadjuvant/adjuvant therapy exceptions per Inclusion Criterion #6.
>30 Gy thoracic radiotherapy within 6 months or non-thoracic radiotherapy within 4 weeks prior to first dose (brain radiotherapy exceptions per Inclusion Criterion #12).
Trial design
Design model
Parallel
Treatments tested in this trial
Firmonertinib Mesilate Tablets
DrugUsage and dosage: oral, 240mg, QD。 Medication duration: 21 days as a cycle, until intolerable toxicity, loss of clinical benefit, disease progression (confirmed by BICR), death or other anti-tumor treatment (whichever occurs first).
Pemetrexed Disodium for Injection
DrugUsage and dosage: 500mg/m2, intravenous infusion. Medication duration: 21 days as a cycle, D1 administration, until the occurrence of intolerable toxicity, loss of clinical benefit, disease progression (confirmed by BICR), death or other anti-tumor treatment (whichever occurs first).
Cisplatin for injection
DrugUsage and dosage: 75 mg/m2, i.v. Medication duration: 21 days as a cycle, D1 administration, up to 4 cycles.
Carboplatin Injection
DrugUsage and dosage: give the drug according to AUC 5 mg/ml, intravenous drip. Medication duration: 21 days as a cycle, D1 administration, up to 4 cycles.
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: FirmonertinibExperimental treatment 1 intervention
Group B: chemotherapyActive comparator 3 interventions
Trial outcomes
Primary outcomes
1
Progression-free survival (PFS) assessed by the Independent Review Committee (BICR) according to RECIST v1.1.
The time from the date of randomization to the date of first documentation of disease progression (assessed according to RECIST v1.1 criteria) or death from any cause, whichever occurred first.
Time frame
Up to 3 yearsSecondary outcomes
1
Overall survival (OS)
Time frame
Up to 3 years2
The incidence and severity of adverse events (AES) were determined according to NCI CTCAE V5.0
Time frame
Up to 3 years3
Patient Reported Outcomes by EORTC QLQ LC13 questionnaire
To assess the impact of firmonertinib on patients' disease-related symptoms and health related quality of life (HRQoL).
Time frame
Up to 3 years4
Patient Reported Outcomes by EORTC QLQ-C30 questionnaire
To assess the impact of firmonertinib on patients' disease-related symptoms and health related quality of life (HRQoL).
Time frame
Up to 3 yearsSponsors and contacts
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Source ClinicalTrials.gov